Subjective and Objective Results With CI Electrode Types

NCT ID: NCT03515473

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-13

Study Completion Date

2017-11-30

Brief Summary

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Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.

Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold \[ESRT\], neural response telemetry threshold \[T-NRT\] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.

Detailed Description

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Conditions

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Cochlear Implant

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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CI532

Patients with CI532 cochlear implant

cochlear implant

Intervention Type DEVICE

cochlear implant surgery

CI522

Patients with CI522 cochlear implant

cochlear implant

Intervention Type DEVICE

cochlear implant surgery

CI512

Patients with CI512 cochlear implant

cochlear implant

Intervention Type DEVICE

cochlear implant surgery

Interventions

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cochlear implant

cochlear implant surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* successful cochlear implantation with CI532 or CI512 or CI522
* gave informed consent

Exclusion Criteria

* unsuccessful cochlear implantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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László Rovó

Professor Head of Otorhinolaryngology Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery

Szeged, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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CI-001

Identifier Type: -

Identifier Source: org_study_id

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